US Supreme Court in favor of R.J. Reynolds to challenge FDA denials

US Supreme Court in favor of R.J. Reynolds to challenge FDA denials

On June 20th, the US Supreme Court ruled 7-2 in favor of RJ Reynolds Vapor company, making it easier for them to file lawsuits against the FDA’s decision to block their products from entering the market. This ruling may give vape companies more freedom to choose courts to challenge federal regulation. The case was filed by RJ Reynolds Vapor Co., involving the FDA’s refusal of authorization for its Vuse Alto vape product. The majority opinion is that retailers and other businesses affected by FDA decisions can also file lawsuits in their location. Opposing opinions warn that this will weaken regulatory effectiveness. Previously, the FDA strengthened its ban on sweet flavored vapes after a surge in teenage vaping, but this ruling may change the game between the industry and regulatory agencies.

Vuse Alto Disposable Vape

At the time of this ruling, major vape companies were opposing the federal government’s years long regulatory crackdown on vapes. It is expected that this ruling will give vape companies more autonomy in deciding which judges will hear lawsuits against vape institutions.

In a ruling in April, judges reversed their stance on vapes and supported the FDA’s ruling, maintaining a comprehensive ban on most sweet flavored vapes implemented after a surge in teenage vaping.

The current case is filed by Reynolds Vapor company, which had already sold a range of popular berry and menthol flavored vape products before the FDA began regulating the market under the Tobacco Control Act in 2016.

The FDA refused to authorize the company’s Vuse Alto product, and Justice Amy Coney Barrett wrote in the majority opinion that this order “sounded the death knell for a large portion of the vape market.

The company is headquartered in North Carolina and typically can only challenge the FDA in local courts or in Washington D.C., where the FDA headquarters is located. However, the company teamed up with a Texas company that sells its products and filed a lawsuit locally. The conservative US Fifth Circuit Court of Appeals allows the lawsuit to continue, ruling that any company whose business has been damaged by the FDA ruling can file a lawsuit.

The FDA has appealed to the Supreme Court, stating that Reynolds Vapor company is attempting to find a court favorable to its arguments.
However, the judges found that the law does allow other businesses affected by FDA decisions, such as vape sellers, to file lawsuits in their state.
Justice Ketanji Brown Jackson, who holds a different opinion, and Justice Sonia Sotomayor unanimously stated that she will stand on the side of the institution.

reference documents: U.S. Supreme Court Backs RJR, Broader Legal Challenges to FDA – Tobacco Reporter